7. November 2011 13:08
The EMA is under investigation by the European Anti-Fraud Office (OLAF) over alleged conflicts of interest.
The investigation was raised by Michèle Rivasi, a French Member of the European Parliament, who claims independent oversight by the EMA is impossible due to the majority of its budget coming from pharma.
OLAF told The Independent the investigation opened in July, but “for reasons of judicial secrecy", could not give any further details.
It’s believed the inquiry relates to the Servier’s controversial diabetes drug Mediator. The medication was withdrawn from the European market in 2009, ten years after concerns were first raised the treatment may be responsible for fatal heart problems.
Mediator was on the market for more than three decades and was used as a weight loss drug taken by an estimated 5 million people in France alone, plus countless more in Italy and Spain. It is estimated the drug caused up to 2,000 deaths during its time on the market before it was withdrawn.
The fallout from the scandal saw the French regulator, the Health Products Safety Agency, overhauled and its chief executive resign after an official report found it had “failed in its duties”.
The EMA was formed back in 1995 to provide a collective voice on drug regulation systems in the EU. The Agency has been attempting to its transparency with a series of new working principles and said in October it had “strengthened the rules on how it handles potential conflicts of interest of its staff and experts" after criticism by the Budgetry Control Committee.
A spokesman for the Agency said it was aware of the inquiry but had yet to see any allegations. “We have a robust process for dealing with conflicts of interest. It is transparent and there's no attempt to hide anything,” he said.